Microcirculatory Vasomotor Changes in Type 2 Diabetes With Peripheral Neuropathy
NCT03847779 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108
Last updated 2020-11-13
Summary
Microcirculatory flow is subject to cyclic changes under the influence of heart rate, respiration, myogenic activity, neurogenic factors and endothelial factors. Microcirculatory oscillations (vasomotion) contribute significantly to tissue perfusion. Vasomotion analysis allowed to discriminate normoglycemic subjects, prediabetic subjects and diabetic subjects. Furthermore, changes in vasomotion can precede the emergence of global signs of microangiopathy complications in type 2 diabetes. In fact, few studies reported impaired vasomotion in type 2 diabetes with peripheral neuropathy. Vasomotion analysis after vasodilator (6-min walking test and hyperthermia) and after vasoconstrictor (foot lowering) stimulus could be an effective diagnostic tool to sharpen the diagnostic.
Objectives and Methodology: to study vasomotion at baseline and after exercise, hyperthermia and foot lowering within 3 groups of patients: diabetic without peripheral neuropathy, diabetic with subclinical peripheral neuropathy and diabetic with peripheral neuropathy and one group of sex- age- and body mass index-matched healthy control subjects.
All the subjects will benefit from a clinical, anthropometric, level of physical activity and biological evaluations. Type 2 diabetes participants will benefit from neuropathy evaluation. In addition, cutaneous microcirculation (perfusion and vasomotion) by means of Laser Doppler Flowmetry and Laser Speckle Imaging will be recorded at rest and after different stimuli (exercise, hyperthermia and foot lowering).
Conditions
- Diabetic Neuropathy Peripheral
- Small Vessel Disease of Diabetes Mellitus
- Vasodilation
- Vasoconstriction
Interventions
- OTHER
-
"Rest"
Cutaneous perfusion and vasomotion assessment at rest in supoine position
- OTHER
-
"Exercise"
Cutaneous perfusion and vasomotion assessment after the 6minute-wlaking test
- OTHER
-
"Foot lowering"
Cutaneous perfusion and vasomotion assessment after foot lowering
- OTHER
-
"Hyperthermia"
Cutaneous perfusion and vasomotion assessment during hyperthermia
Sponsors & Collaborators
-
University of Avignon
lead OTHER
Principal Investigators
-
Eric Benamo, MD · Centre Hospitalier Avignon
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-02-04
- Primary Completion
- 2020-06-30
- Completion
- 2020-06-30
Countries
- France
Study Locations
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